MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ 20 ML SYRINGE

Catalog Number 990173

Device Problems Crack (1135); Excess Flow or Over-Infusion (1311)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Overdose (1988); Chest Tightness/Pressure (2463)

Event Date 08/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).Device evaluation: result - a visual inspection of 40 retention samples was performed and the reported defect of cracks were not evidenced.The customer returned one sample, which was visually inspected and a crack was noted.A review of the device history record revealed no abnormalities in the manufacture of the reported lot 5224484.The products undergo a rigorous inspection process at various stages of the production process.All inspections complied with the product specifications.Conclusion - bd was not able to duplicate or confirm the customer's indicated defect of cracks in the nozzle.Ater analyzing the history of the lot, it is noted that there are no instances of records that may be related to the defect reported by the customer.Based on information provided by the client, it can be stated that the product was not used in accordance with manufacturer's recommendations.Bd syringes manufactured in (b)(4) are not indicated for use in infusion pumps.According to the production history records the product in question is in accordance with the bd specifications.

Event Description

It was reported that the patient was receiving a fentanyl infusion from the suspect device on a non-bd infusion pump.The medication had been infusing between 3 and 4 hours when the patient experienced bradycardia, hypotension and chest stiffness.The infusion was stopped, the doctor administered naloxone, and the patient's ventilation was assisted with an ambu bag.It was noted that there was a crack at the location of the luer lock, "which led to a greater infusion than prescribed and worsened the child's clinical condition".The patient was discharged to the hospital sector from the pediatric icu on (b)(6) 2016 and later discharged from the hospital on (b)(6) 2016.There was no extension of the hospital stay and no permanent harm occurred to the patient.

• Brand Name: BD PLASTIPAK¿ 20 ML SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5970251
• MDR Text Key: 55369542
• Report Number: 3003916417-2016-00002
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Catalogue Number: 990173
• Device Lot Number: 5224484
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 MO